Cannabidiol in Opioid Use Disorder and Chronic Pain

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04587791
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 400 mg Cannabidiol — DRUG
    Participants will receive 400 mg CBD
  • 800 mg Cannabidiol — DRUG
    Participants will receive 800 mg CBD
  • 1200 mg Cannabidiol — DRUG
    Participants will receive 1200 mg CBD
  • Beta carotene oral solution without CBD — DRUG
    Participants will receive beta carotene oral solution without CBD (placebo)

Study Details

This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of Cannabidiol (CBD) on measures of pain and opioid craving in outpatients with opioid use disorder (OUD) receiving medication-assisted treatment with methadone or buprenorphine. With a duration of approximately 4 weeks, participants will come to the testing site for a total of five times: one initial screening session, and four experimental sessions where study medication, CBD, will be administered, separated by at least 72 hours to limit carryover effects.

Key Dates

Start date
Dec 8, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: CBD 400 mg
    CBD 400 mg
  • Active Comparator: CBD 800 mg
    CBD 800mg
  • Active Comparator: CBD 1200 mg
    CBD 1200 mg
  • Placebo Comparator: Beta carotene oral solution
    Beta carotene oral solution without CBD

Primary Outcome Measure

Safety and tolerability of CBD measured by the Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: Baseline (30 minutes before the administration of CBD) and +240 minutes after the administration of CBD ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Veterans Affairs HospitalWest HavenConnecticut06516
Joao De Aquino, M.D.
[email protected]
203-932-5711
Joao De Aquino, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Haven, CT

By research site
Department of Veterans Affairs Hospital· West Haven, CT

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